OUTSOURCING RAPID METHODS
A new alternative to bringing a rapid screening system in-house is to partner with a contract analytical lab that offers rapid
detection as a service. With overnight shipping widely available, there's still much to be gained by being able to release
products within two days.
Look for an accredited lab that is certified in current good manufacturing practices. Such labs will understand the demands
of the regulated environment. Ask about their experience with validation services and, if there's a future possibility of
bringing testing in-house, with method transfer. In addition to having a robust rapid screening system, the lab should be
equipped to perform follow-up testing on any samples that test positive.
Some laboratoies are capable of mapping organisms at the genetic level. This strain typing process uses repetitive extragenic
palindromic sequence polymerase chain reaction (rep-PCR) to identify and track organisms. Because it can be used to catalog
any mutations or seasonal changes over time, strain typing can be a significant benefit to facilities plagued by a recurring
ADOPTING RAPID METHODS IN PHARMA
As a growth-based method, AK-amplified bioluminescence has the advantage of being able to test products with a wide range
of physical characteristics. This includes clear, opaque, highly pigmented, acidic, and viscous products, whether filterable
or not. Both AK-amplified and traditional methods rely on batch or lot sampling, enrichment, and incubation. While the traditional
method depends on laboratory technicians visually inspecting hundreds of samples one at a time over multiple days, the rapid
method assays up to 120 samples in about one hour using a light-measuring instrument called a luminometer. Results are objectively
recorded and presented in clear, color-coded tables and graphics, so no "judgment calls" are needed to interpret the results.
Transitioning pharmaceuticals and other regulated products to a rapid release method is straightforward and is, in fact,
encouraged by many global regulatory bodies, including FDA. A contract laboratory with experience in this method should be
able to assist its clients in validating their product or group of products for routine release using a rapid method. This
typically entails side-by-side testing to ensure the rapid method is as sensitive as the traditional method. Once this comparability
protocol is completed and the validation data is submitted, the RMM is effectively implemented.
A good RMM provider may have regulatory compliance expertise on staff, as well as drug master files (DMFs) accepted by FDA.
DMFs include data for specificity, limit of detection, robustness, ruggedness, and equivalence, and can be used to supplement
or streamline the validation of a company's rapid system. This may save significant time in both preparation of regulatory
filings, and in FDA's review and approval process.
Tina Sturgill is senior director of biologcial sicences at Celsis Analytical Services, St. Louis, MO, TSturgill@celsis.com